510(k) K090006
K090006 is an FDA 510(k) premarket notification submitted by Lifebridge Medizintechnik AG for the device "LIFEBRIDGE B2T, MODEL 7001". The FDA issued a decision of Substantially Equivalent on October 15, 2009. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Lifebridge Medizintechnik AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2009
- Date Received
- January 2, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4220
- Review Panel
- CV
- Submission Type